Evidence
register
Every percentage printed anywhere in this catalogue carries a record number. This is the register those numbers resolve to: design, blinding, sample size, duration, endpoint and effect size — with no step in between.
How to read a record
RANDOMISED & CONTROLLED
Randomised or split-face, vehicle- or active-controlled, blinded to at least the investigator. The only design that isolates the molecule from the vehicle, the routine and the season.
CONTROLLED, LIMITED
Controlled but unblinded, small, or ex vivo. Directionally useful. Not enough on its own to justify a claim on a bottle.
MECHANISTIC ONLY
In vitro or open-label. Tells you a pathway exists. Tells you nothing about what happens on a face.
Every record below is real. Each carries the document it was read from, the design, the number of subjects, the duration, the endpoint as the sponsor defined it, and — where one exists — what happened to the comparator arm. Nothing here is authored by us. Where a record reports a result that reflects badly on the drug, it is in the register for that reason.
The register
- REF-01A
Fine facial wrinkling — any improvement
Four multi-centre randomised trials, vehicle-controlled, on a comprehensive sun-avoidance programme
DOUBLE-BLINDN = 55924 WEEKSEFFECT SIZE+21%SAMPLE SIZE559 - REF-02B
Fine facial wrinkling — minimal or mild improvement
Single-centre randomised controlled trial in darkly pigmented, mostly African-American subjects
NOT STATEDN = 10724 WEEKSEFFECT SIZE-14%SAMPLE SIZE107 - REF-03A
Melasma cleared — severity score of zero
Randomised, active-controlled against all three two-drug combinations in the identical vehicle
INVESTIGATOR-ASSESSEDN = 3388 WEEKSEFFECT SIZE+23%SAMPLE SIZE338 - REF-04A
Melasma cleared — severity score of zero
Randomised, active-controlled against all three two-drug combinations in the identical vehicle
INVESTIGATOR-ASSESSEDN = 3038 WEEKSEFFECT SIZE+9%SAMPLE SIZE303 - REF-05A
IGA clear or almost clear
Randomised, vehicle-controlled, co-primary endpoints
DOUBLE-BLINDN = 68312 WEEKSEFFECT SIZE+26.8%SAMPLE SIZE683 - REF-06A
Inflammatory lesion count — mean reduction
Randomised, vehicle-controlled, co-primary endpoints
DOUBLE-BLINDN = 68812 WEEKSEFFECT SIZE+22.3%SAMPLE SIZE688 - REF-07A
IGA success — clear or minimal, two-step reduction
Multicentre randomised, vehicle-controlled; mean subject age 50.6, range 19–92
DOUBLE-BLINDN = 96112 WEEKSEFFECT SIZE+8.7%SAMPLE SIZE961 - REF-08A
IGA success — clear or minimal, two-step reduction
Multicentre randomised, vehicle-controlled; mean subject age 50.6, range 19–92
DOUBLE-BLINDN = 40112 WEEKSEFFECT SIZE+10.9%SAMPLE SIZE401 - REF-09A
IGA clear or almost clear
Randomised, placebo-controlled, multi-centre Phase 3
DOUBLE-BLINDN = 25116 WEEKSEFFECT SIZE+11.3%SAMPLE SIZE251 - REF-10B
Long-term effect on bacterial flora
In vivo microbiological study at comparable drug exposure, oral cavity, skin, intestinal tract and vagina
N/AN = 078 WEEKSEFFECT SIZE0%SAMPLE SIZE0 - REF-11A
Two-grade improvement on both erythema scales
Randomised, vehicle-controlled, parallel-group; composite of clinician and subject scales at four timepoints
DOUBLE-BLINDN = 4404 WEEKSEFFECT SIZE+12%SAMPLE SIZE440 - REF-12A
Two-grade improvement on both erythema scales
Randomised, vehicle-controlled; composite of clinician and patient scales at four timepoints
DOUBLE-BLINDN = 2604 WEEKSEFFECT SIZE+20%SAMPLE SIZE260 - REF-13A
EGSS success — clear or almost clear, two-grade reduction
Multicentre randomised, vehicle-controlled
DOUBLE-BLINDN = 82012 WEEKSEFFECT SIZE+9.6%SAMPLE SIZE820 - REF-14A
Application-site dryness
Pooled safety analysis of two randomised, vehicle-controlled trials
DOUBLE-BLINDN = 155012 WEEKSEFFECT SIZE-3%SAMPLE SIZE1550 - REF-15A
EGSS success — clear or almost clear, two-grade reduction
Multicentre randomised, vehicle-controlled; treatment difference 12.5% (95% CI 7.1–17.9)
DOUBLE-BLINDN = 81312 WEEKSEFFECT SIZE+12.5%SAMPLE SIZE813 - REF-16A
IGA success — two-point reduction, clear or almost clear
Multicentre randomised, vehicle-controlled; treatment difference 14.3% (95% CI 8.9–19.7)
DOUBLE-BLINDN = 72912 WEEKSEFFECT SIZE+14.3%SAMPLE SIZE729 - REF-17B
HPA axis suppression at day 14 (all recovered by four weeks)
Open-label pharmacokinetic study, twice-daily application, adults and adolescents
OPEN-LABELN = 422 WEEKSEFFECT SIZE0%SAMPLE SIZE42 - REF-18A
IGA success — two-grade improvement, clear or almost clear
Randomised, multicentre, parallel-group, vehicle-controlled
DOUBLE-BLINDN = 121212 WEEKSEFFECT SIZE+16.6%SAMPLE SIZE1212 - REF-19A
Erythema worse than baseline at any visit
Investigator assessment at every visit against each subject's own baseline, pooled across both trials
DOUBLE-BLINDN = 240812 WEEKSEFFECT SIZE-36.6%SAMPLE SIZE2408 - REF-20A
IGA treatment success — clear or almost clear, two-grade improvement
Randomised 2:1, vehicle-controlled; treatment difference 20.6% (95% CI 11.2–30.0)
DOUBLE-BLINDN = 4578 WEEKSEFFECT SIZE+21.5%SAMPLE SIZE457 - REF-21A
Scalp IGA treatment success
Randomised 2:1, vehicle-controlled; treatment difference 37.1% (95% CI 27.1–47.1)
DOUBLE-BLINDN = 4328 WEEKSEFFECT SIZE+38.6%SAMPLE SIZE432 - REF-22A
Global Eyelash Assessment — at least a one-grade increase
Multicentre randomised, vehicle-controlled, parallel
DOUBLE-MASKEDN = 27816 WEEKSEFFECT SIZE+60%SAMPLE SIZE278 - REF-23B
Total lesion count — mean percent reduction
Randomised, vehicle-controlled
DOUBLE-BLINDN = 14312 WEEKSEFFECT SIZE+22%SAMPLE SIZE143 - REF-24B
Systemic bioavailability, repeated daily application
Radiolabelled cumulative excretion in healthy volunteers, single and repeated daily application
OPEN-LABELN = 444 WEEKSEFFECT SIZE0%SAMPLE SIZE44CITED BY- — NOT CURRENTLY CITED
- REF-25A
Clinical success at week 24 — twelve weeks after the last application
Randomised, vehicle-controlled, with a twelve-week post-treatment observation period
DOUBLE-BLINDN = 44724 WEEKSEFFECT SIZE+11%SAMPLE SIZE447 - REF-26A
Total lesion count — median percent reduction
Randomised, vehicle-controlled, facial acne suitable for topical monotherapy
DOUBLE-BLINDN = 43612 WEEKSEFFECT SIZE+20%SAMPLE SIZE436 - REF-27A
IGA treatment success — clear or almost clear, two-grade reduction
Multicentre randomised, vehicle-controlled; treatment difference 26.7% (95% CI 16.7–36.8); mean subject age 51
DOUBLE-BLINDN = 36112 WEEKSEFFECT SIZE+26.7%SAMPLE SIZE361 - REF-28A
IGA success — clear or almost clear, two-point decrease
Multicentre randomised, placebo-controlled; 51% of subjects adults, 15% Black or African American
DOUBLE-BLINDN = 96812 WEEKSEFFECT SIZE+11.4%SAMPLE SIZE968 - REF-29A
Complete (100%) clearance of lesions in the treatment field at day 57
Double-blind, vehicle-controlled, five-day course; average subject age 70, range 45 to 96
DOUBLE-BLINDN = 3518 WEEKSEFFECT SIZE+42%SAMPLE SIZE351 - REF-30A
Erythema worse than baseline, any severity
Investigator-graded local skin reactions in the treatment area, pooled across both Phase 3 trials
DOUBLE-BLINDN = 7028 WEEKSEFFECT SIZE-57%SAMPLE SIZE702 - REF-31A
No or minimal acne on the Global Acne Assessment Score
Randomised, double-blind, vehicle-controlled; analysis excludes subjects minimal at baseline
DOUBLE-BLINDN = 138612 WEEKSEFFECT SIZE+10%SAMPLE SIZE1386CITED BY